Prescribing, Off-Label Clinical Trial
Official title:
A Letter From the CMO in England to Reduce Antibiotic Prescribing in General Practice: A Randomized Controlled Trial Comparing Monitoring and Feedback (With and Without Graphs), and Social Norms Feedback (Without and Without a Specific Case Study of Patient Harm)
This trial aims to reduce inappropriate prescription of antibiotics and broad spectrum
antibiotics by general practitioners (GPs) in England. Unnecessary prescriptions are defined
as those that do not improve patient health outcomes. The intervention is to send GPs a
letter from the Chief Medical Officer (CMO) that gives feedback on their practice's
prescribing levels.
There will be three intervention samples:
1. practices whose prescribing in the past year was under the new target of 0.965 items per
STAR-PU but who would exceed the target if they had a 5% increase in prescribing; trial
compares prescribing of practices whose GPs receive a letter informing them that their
practice's prescribing is just under the new target to that of practices that are not
sent a letter
2. Practices whose prescribing in the past year was above the new target but who not in the
top 20% of prescribers; trial compares prescribing of practices whose GPs receive a
letter informing them that their practice's prescribing exceeds the new target to
practices who get a letter that includes a graph showing their prescribing relative to
the target and to practices that are not sent a letter
3. Practices that are currently in the top 20% of prescribers; trial compares effect on
prescribing of a feedback letter with a social norms message (current standard practice
for this group) to a letter informing GPs that their practice's prescribing exceeds the
new target and to a letter with a social norms message, that includes a specific example
of a case of patient harm caused by antimicrobial resistance.
The study will involve three trials, each conducted as non-blinded randomised controlled
trial, with GP practices as the unit of randomisation.
Trial 1 Targeting practices whose prescribing in the past year was under the new target but
who would exceed the target if they had a 5% increase in prescribing
- Control: No letter
- Intervention: Letter informing them that their practice's prescribing is just under the
new target (Letter A) Trial hypothesis: Sending a letter to GPs whose practices are just
under the new prescribing target will reduce antibiotic prescribing
Trial 2 Targeting practices whose prescribing in the past year was above the new target but
who not in the top 20% of prescribers
- Control: No letter
- Intervention 1: Letter informing them that their practice's prescribing exceeds the new
target (Letter B1)
- Intervention 2: Letter informing them that their practice's prescribing exceeds the new
target with a graph representing prescribing relative to the target (Letter B2)
Hypotheses: (i) Sending a letter to GPs whose practices missed the new prescribing
target will reduce their prescribing; (ii) A letter with a graph will be more effective
than a letter without a graph.
Trial 3 Targeting practices that are currently in the top 20% of prescribers
- Control: Current standard practice, a social norms message, that their practice is in
the top 20% of prescribers (Letter C1)
- Intervention 1: Letter informing them that their practice's prescribing exceeds the new
target (Letter C2)
- Intervention 2: Social norms message, that they are in the top 20%, with a specific
example of a case of patient harm caused by antimicrobial resistance (Letter C3)
Hypotheses: (i) A letter with a social norms message and a specific example of a case where a
patient came to harm will be more effective than a feedback letter without a specific
example; (ii) A letter telling GPs that they missed the prescribing target will be no less
effective than a letter with social norms feedback
For each letter, there will be two versions, one for practices whose prescribing has
increased by > 5% in the previous year, informing them of that their prescribing has
increased since the previous year, and one for practices whose prescribing has not been
increasing.
The letters will signpost GPs to resources to help address patient demand for inappropriate
antibiotic prescribing, recognising that many GPs feel that patients expect antibiotics and
that GPs may find it difficult to have the necessary patient conversations, especially within
a short consultation. As with previous letters, these letters will advise GPs of actions that
they can take to reduce inappropriate prescribing, supporting them to have conversations with
patients, and there will be TARGET leaflets enclosed.
Power calculation All trials are powered to detect a 2% reduction in prescribing at a
significance level of 0.05 with a power of 80%.
Statistical analysis plan In order to test our hypotheses, the investigators will use a fixed
effects panel regression model, with time trends accounting for seasonal effects, to estimate
the effect of treatment status on prescribing. The investigators will also run ANCOVAs for
each month separately and one covering the whole six months of the trial. Analysis will
control for baseline prescribing rates and for whether practices got the version of the
letter saying that their prescribing has been increasing.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03862794 -
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| Completed |
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N/A | |
| Completed |
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